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Summary

for people ages up to 21 years (full criteria)
at Oakland, California and other locations
study started

Description

Summary

This clinical trial studies cancer survivors to identify those who are at increased risk of developing late-occurring complications after undergoing treatment for childhood cancer. A patient's genes may affect the risk of developing complications, such as congestive heart failure, heart attack, stroke, and second cancer, years after undergoing cancer treatment. Genetic studies may help doctors identify survivors of childhood cancer who are more likely to develop late complications.

Official Title

Key Adverse Events After Childhood Cancer

Details

PRIMARY OBJECTIVES:

  1. To identify key adverse events developing in patients (cases) with a primary cancer diagnosed at age 21 or younger.

II. To characterize the key adverse events with respect to the nature of the primary malignancy (pathology, stage) and coded details of the therapeutic protocol.

III. To identify treatment-related and demographic risk factors through a direct comparison of the case-group and controls identified from the remaining patients with the same primary diagnosis.

IV. To compare the frequency of mutations or polymorphisms in specific candidate genes in cases and controls, using constitutional deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) from the cases and controls.

  1. To explore the role and nature of gene-environment interaction in the development of key adverse events.

OUTLINE:

DNA and RNA from peripheral blood or buccal sample of patients is analyzed for the presence of polymorphisms in candidate genes associated with an increased risk of late-occurring complications.

Keywords

Cancer Survivor Cardiovascular Complication Malignant Childhood Neoplasm

Eligibility

For people ages up to 21 years

Inclusion Criteria:

  • ELIGIBILITY CRITERIA - CASES
  • Diagnosis of primary cancer at age 21 or younger, irrespective of current age
  • No prior history of allogeneic (non-autologous) hematopoietic cell transplant
  • Development of one of the following key adverse events at any time following initiation of cancer therapy:
  • Cardiac dysfunction; please note: case enrollment has been closed due to achievement of target accrual
  • Ischemic stroke (IS)
  • Subsequent malignant neoplasm (SMN)
  • Avascular necrosis (AVN); please note: case enrollment has been closed due to achievement of target accrual
  • Submission of a blood specimen (or in certain cases a buccal cell specimen) to the Clinical Pharmacokinetics Laboratory at St. Jude Children's Research Hospital as per the requirements; please note: if a patient is currently receiving active cancer treatment, it is preferable to obtain the blood sample at a time when the patient's white blood cell (WBC) is > 2,000
  • Written informed consent from the patient and/or the patient's legally authorized guardian
  • In active follow up by a COG institution; active follow up will be defined as date of last visit or contact by a COG institution within the past 24 months; any type of contact, including contact specifically for participation in ALTE03N1, qualifies as active follow-up; please note: treatment on a COG (or legacy group) therapeutic protocol for the primary cancer is NOT required
  • ELIGIBILITY CRITERIA - CONTROLS
  • CONTROL: Diagnosis of primary cancer at age 21 or younger, irrespective of current age
  • CONTROLS: No prior history of allogeneic (non-autologous) hematopoietic cell transplant
  • CONTROLS: No clinical evidence of any of the following key adverse events:
  • Cardiac dysfunction (CD); please note: if a patient is currently receiving active cancer treatment, it is preferable to obtain the blood sample at a time when the patient's WBC is > 2,000
  • Myocardial infarction (MI)
  • Ischemic stroke (IS)
  • Avascular necrosis (AVN)
  • Subsequent malignant neoplasm (SMN)
  • CONTROLS: Submission of a blood specimen (or in certain cases a buccal cell specimen)to the Clinical Pharmacokinetics Laboratory at St. Jude Children's Research Hospital as per the requirements
  • CONTROLS: Written informed consent from the patient and/or the patient's legally authorized guardian
  • CONTROLS: In active follow up by a COG institution; active follow up will be defined as date of last visit or contact by a COG institution within the past 24 months; any type of contact, including contact specifically for participation in ALTE03N1,qualifies as active follow-up; please note: treatment on a COG (or legacy group)therapeutic protocol for the primary cancer is NOT required

Locations

  • Kaiser Permanente-Oakland accepting new patients
    Oakland, California, 94611, United States
  • Lucile Packard Children's Hospital Stanford University accepting new patients
    Palo Alto, California, 94304, United States
  • Children's Hospital Los Angeles accepting new patients
    Los Angeles, California, 90027, United States
  • Cedars Sinai Medical Center accepting new patients
    Los Angeles, California, 90048, United States
  • City of Hope Comprehensive Cancer Center accepting new patients
    Duarte, California, 91010, United States
  • Southern California Permanente Medical Group accepting new patients
    Downey, California, 90242, United States
  • Mattel Children's Hospital UCLA accepting new patients
    Los Angeles, California, 90095, United States
  • UCLA / Jonsson Comprehensive Cancer Center accepting new patients
    Los Angeles, California, 90095, United States
  • Nevada Cancer Research Foundation CCOP accepting new patients
    Las Vegas, Nevada, 89106, United States
  • Children's Specialty Center of Nevada II accepting new patients
    Las Vegas, Nevada, 89109, United States
  • Sunrise Hospital and Medical Center accepting new patients
    Las Vegas, Nevada, 89109, United States

Details

Status
accepting new patients
Start Date
Sponsor
Children's Oncology Group
ID
NCT00082745
Study Type
Observational
Last Updated
August 1, 2017